USP1231翻译-关于微生物增菌培养的考虑

USP --1231WATER FOR PHARMACEUTICAL PURPOSES
MICROBIAL ENUMERATION CONSIDERATIONS
关于微生物增菌培养的考虑
The objective of a water system microbiological monitoring program is to provide sufficient information to control and assess the microbiological quality of the water produced. Product quality requirements should dictate water quality specifications. An appropriate level of control may be maintained by using data trending techniques and, if necessary, limiting specific contraindicated microorganisms. Consequently, it may not be necessary to detect all of the microorganisms species present in a given sample.
水系统微生物监测的目的是为控制、评定水的微生物质量提供充足的信息。

产品质量要求应规定水的质量规格。

可以通过数据趋势技术，或有必要的话,通过限制特定的控制菌来进行适当程度的控制。

因此不必检测样品中的所有微生物种类。

The monitoring program and methodology should indicate adverse trends and detect microorganisms that are potentially harmful to the finished product, process, or consumer. Final selection of method variables should be based on the individual requirements of the system being monitored.
监测程序和方法应显示不利的趋势并检测那些对终产品、加工过程或消费者有潜在伤害的微生物。

方法变量的最终选择应基于所监测系统的要求。

It should be recognized that there is no single method that is capable of detecting all of the potential microbial contaminants of a water system. The methods used for microbial monitoring should be capable of isolating the numbers and types of organisms that have been deemed significant relative to in-process system control and product impact for each individual system.
应该清楚的是没有一种方法可以检测水系统中所有的潜在微生物污染。

用于微生物监测的方法应可以区分那些被认为与现行系统控制密切相关及对各系统的产品有影响的微生物的种类和数量。

Several criteria should be considered when selecting a method to monitor the microbial content of a pharmaceutical water system. These include method sensitivity, range of organisms types or species recovered, sample processing throughput, incubation period, cost, and methodological complexity.
当选择监测制药用水系统微生物含量的方法时应考虑几个标准。

包括方法的灵敏度，微生物的种类及其回收率，样品处理能力，培养时长，费用和方法学适用性。

An alternative consideration to the use of the classical “culture” approaches is a sophisticated instrumental or rapid test method that may yield more timely results. However, care must be exercised in selecting such an alternative approach to ensure that it has both sensitivity and to classical culture approaches, which are generally considered the accepted standards for microbial enumeration.相比经典的培养计数方法来说,还有其他一些可以采用的方法:精巧的仪器测试方法或快速测试方法,它们可以更及时的出具结果.不过,选用这些方法时必须特别注意,要确保这些方法的灵敏度及与经典的培养计数法间的相关性(经典的培养计数法被普遍认为是标准的微生物计数方法. Consideration should also be given to the timeliness of microbial enumeration testing after sample collection. The number of detectable planktonic bacteria in a sample collected in a scrupulously clean sample container will usually drop as time passes. The planktonic bacteria within the sample will tend to either die or to irretrievably adsorb to the container walls reducing the number of viable planktonic bacteria that can be withdrawn from the sample for testing. 检测中,也要考虑到样品采集后进行检测的时限性.洁净容器中收集的样品所含可检测浮游微生物的数量会随着时间减少；样品中的浮游微生物趋向于死亡和对容器壁的不可逆黏附，从而降低了可从样品中脱离出来而被检测到的微生物的数量。

The opposite effect can also occur if the sample container is not scrupulously clean and contains a low concentration of some microbial nutrient that could promote microbial growth within the sample container. 与上面所述恰恰相反的情况也会发生，如果样品容器没有作过仔细的清洗，含有低浓度的可以促进微生物生长的营养物质。

Because the number of recoverable bacteria in a sample can change positively or negatively over time after sample collection, it is best to
test the samples as soon as possible after being collected.因为样品采集后，随着时间的推移，样品中所含的可回收微生物数会相应地增加或减少；所以，尽可能样品采集后即进行检测。

If it is not possible to test the sample within about 2 hours of collection, the sample should be held at refrigerated temperatures (2 to 8) for a maximum of about 12 hours to maintain the microbial attributes until analysis. 若不能在样品采集后2小时内对其进行检测，那么应当将样品低温存放——2to 8，最长允许存放12小时，以此来保持微生物的生理特性。

In situations where even this is not possible (such as when using off-site contract laboratories), testing of these refrigerated samples should be performed within 48 hours after sample collection. 当如上所述进行低温In the delayed testing scenario, the recovered microbial levels may not be the same as would have been recovered had the testing been performed shortly after sample collection. Therefore, studies should be performed to determine the existence and acceptability of potential microbial enumeration aberrations caused by protracted testing delays.。